# K150873: CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System

- Pathway: 510(k) (Traditional)
- Applicant: Accuray Incorporated
- Decided: Jul 1, 2015 after 91 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CyberKnife® M6™ System with InCise™ Multileaf Collimator: named in the summary without a submission number

## Most influential descendants
- K171804: Zap-X Radiosurgery System (2017), 3 descendants of its own
- K183698: Zap-X Radiosurgery System (2019), 2 descendants of its own
- K161136: Precision Treatment Planning System (2016), 2 descendants of its own
- K211663: Zap-X Radiosurgical System (2021), 1 descendant of its own
- K171086: Accuray Precision Treatment Planning System (2017), 1 descendant of its own

## Recalls of this device
- Sep 26, 2018 · Class II · Z-0408-2019: A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature failure of 
- Apr 10, 2018 · Class II · Z-1696-2019: There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this op

## Indications for use
The CyberKnife® M6™ Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Source page: https://510kreport.com/device/K150873
Methodology: https://510kreport.com/methodology